Extracorporeal bone compressing link and apparatus and method using same

ABSTRACT

An extracorporeal bone compressing link and apparatus and method using same. Active devices that incorporate the extracorporeal bone compressing link can transport and compress bone through external means by acting on conventional bone fasteners including but not limited bone fasteners including but not limited to screws, pins or wires that penetrate through the skin and fixate into bone.

RELATED PATENT APPLICATIONS

This application is a continuation-in-part application that claimspriority to U.S. patent application Ser. No. 17/334,540, entitled“Extracorporeal Bone Compressing Link And Apparatus And Method UsingSame,” filed on May 28, 2021, to William Casey Fox, and the relatedInternational PCT Patent Application Serial No. PCT/US22/31309, entitled“Extracorporeal Bone Compressing Link And Apparatus And Method UsingSame,” filed May 27, 2022, to William Casey Fox. These patentapplications are incorporated herein in their entirety for all purposes.

TECHNICAL FIELD

The present invention relates to active devices that transport andcompress bone through external means by acting on conventional bonefasteners including but not limited pins or wires that penetrate throughthe skin and fixate into bone.

BACKGROUND

Bone fixating devices are generally implants such as plates, screws,rods and staples that reside within the body. The most advanced of thesetechnologies involve shape changing staples of nitinol. These devicesuse nitinol's memory and super elastic properties to return to apre-programmed shape which can pull together and compress bone. They areoften used to bridge fractures or joints to be fused so that they holdthe healing bone interface in contact and provide compression duringbone healing.

Prior to the use of shape changing implants static plates and stapleswere used. These devices often lost fixation and could not storemechanical elastic energy to act like a spring to compress the healingbone. Before plates, screws and staples, skin penetrating pins and wireswere often the only method of providing fixation to bone while healing.These devices are still used today due to their low cost, ease of use,minimally invasive nature but suffer from the inability to providesufficient fixation and cannot reduce and compress bone while healing.

Yet, the use of shape changing implants still involve invasivetechniques where the surgeon operates under the skin. The use of shapechanging materials as a means to heal bones or for use in bone fixation,such as those described in patents of the Applicant (i.e., Fox '979Patent; Fox '370 Patent), utilize implants that change shape only afterbeing implanted under the skin. Thus, even following the use of shapechanging implants, there still remains a partially invasive nature ofthe implant.

The prior art is without a solution to combine the ease and minimallyinvasive nature of percutaneous wires and pins with an extracorporeallink that act on these pins and wires to create a moment and applyforces which causes bone movement and compression deep within the body.

The subject invention accomplishes that goal while providing (1) a guideto place the pins into bone, (2) adjustability of the deep bone appliedforce, and (3) an instrument that retains the shape of the link untilreleased and during removal re-aligns the link so that it can be slidoff the pins or wires. Once pinned and released the link changes shapeto cause the tip of the pin or wire to move and apply forces to the bonein which the pin or wire is located.

SUMMARY OF THE INVENTION

Representative embodiments set forth herein disclose a shape changinglink.

In some embodiments, the link acts on pins or wires that are fixed inbone on a first end, penetrate the skin and are acted on by the link ona second end to apply forces to bones. In certain embodiments, the linkis external to the body.

The link causes bone transport and creates bone-to-bone compression bypulling or imposing inward directed mechanical moments on the portion ofthe wires or pins that are outside of the body. Moments are applied byangular shape change of the link. Pulling or pushing forces are createdby the shortening or lengthening of the link. In some embodiments, thelink can distract bone by lengthening or imposing outward moments thatseparate bones.

Holes in the link receive and during elastic recovery of the link impartforces to the wires or pins. A hole is any feature where the bonefastener can pass through the link to include but not be limited toslots, grooves, a round hole, adjacent tabs or any structure that whenelastic recovery occurs the bone fastener is forced to move or changeangle. The portion of the link with wire holes changes the angle of theholes relative to the wires to impart forces to and creates mechanicalmoments in the wire. The wire hole portion of the link, defined hereinas a pin tower, thickness can be used to adjust the magnitude oftwisting torque imparted to the wire when the hole changes angle. Thisapplied torque causes the distant tip of the wire to move or applyforces if the wire tip is constrained.

The link has a first and second shape. The link is manufactured in afirst shape. The link is retained by an instrument in a second shape. Inthis second shape the holes are aligned so that when wires or pins arepassed through the link they are of a known relative orientation (e.g.,parallel, divergent, convergent), can penetrate the skin and be advancedso that the tip or the wire or pin is implanted in bone. The secondshape transitions to a first shape when the instrument releases thelink. The instrument allows the surgeon to position the link above theskin and insert the pin or wire through the link, skin and into bone.Once a plurality of pins are inserted through the link and into bone theinstrument is operated to release the link so that the link moves towardits first shape.

As the link changes to its first shape the holes try to change alignmentwith the pins or wires. This alignment change pulls, pushes and/orimparts moments to the pin or wire to move the end of the pin in bone orimpart forces to compress bone segments.

The force applied to bone by the pins, wires and link assembly can bechanged through the design of the link or distance of the link abovebone along the length of the wire or pin. Since the force imparted tobone is a function of the length of the wire or pin at the point ofmechanical moment application the surgeon will have operative control ofthe amount of force to be applied.

The link can be fabricated from metals or plastics that exhibit elasticbehavior. This elasticity stores mechanical energy for dynamic andlong-term effect on the fixated bone. Plastic or metal links can befabricated by machining, additive manufacturing, extruding, casting ormolding. Since the link is not body contacting it may be fabricated frommaterials that are not generally considered biocompatible which mightbroaden the window of performance of the system and reduce cost.

The link can further be fabricated so that a spring of coil, leaf, flat,or a host of other designs that can be used in compression, extension,torsion or bending applications to act on the pins, wires or screws thatare fixed into bone. This link spring can be open and visible orenclosed in a housing. The spring can be fabricated from spring steel,stainless steel, super elastic materials like nitinol, plastic or othermaterials that have spring like mechanical behavior.

The housing provides protection for the link, avoids snagging and can bepart of the spring retention and release mechanism.

In surgical use the link holes provide guides for the pin or wireplacement. The instrument holding the link in the second shapefacilitates this operative technique by allowing the surgeon tovisualize the surgical site, the location of the pins, the height of thelink above the skin and then without additional steps in the procedurereleases the link to mechanically act on its pins and wires to createbone compression.

Mechanical forces, grooves, threads, clips, through holes and thehousing can be used to lock the wire, pin or screw into the link. Theselocking features can be part of the link and bone fastener or an addedaccessory.

In general, in one embodiment, the invention features an extracorporeallink for connecting percutaneous bone fasteners that includes anelement. The element includes a plurality of transverse holes. Theplurality of transverse holes are located about the element. Eachtransverse hole in the plurality of transverse holes is capable ofallowing a bone fastener to pass through the transverse hole in theplurality of transverse holes to secure to one or more bone segments.The element is configured in a first configuration. The element isoperable for being held under force in a second configuration. Theelement is operable to move toward the first configuration after beingreleased from the force. The movement toward the first configuration iscapable of applying moments and forces to the bone fastener bymis-aligning the link fastener holes. The moments and forces capable ofbeing applied to the bone fastener are operable to act through the skinto transport and compress the one or more bone segments.

Implementations of the invention can include one or more of thefollowing features:

The extracorporeal link can be operatively positioned in a plurality ofbone fragments.

The material can include one or more cross-sectional geometries.

Each transverse hole in the plurality of transverse holes can be capableof guiding the bone fastener. The bone fastener can be positionedthrough the extracorporeal link, skin, and the bone.

The movement toward the first configuration after being released fromthe force can operatively position the bone fastener to fixate, move orcompress the bone at a desired direction.

The extracorporeal link can be held by a restraining instrument in asterile kit.

The restraining instrument can include a restrainer selected from agroup consisting of pliers, power screws, sliding platens, forceps,needle drivers, and pin tower tubes.

The sterile kit can include but is not limited to one or more of thefollowing the extracorporeal link, the restraining instrument, aplurality of bone fasteners, and a plurality of pin tower tubes.

The extracorporeal link can be operatively connected to a protectivecover that can be fixed, movable or designed to release shape changingfeatures of the link.

The protective cover can include a material selected from a groupconsisting of plastic, rubber, latex, foam, and combinations thereof.

The protective cover can be movable and can operate to cover cut bonefasteners or release other shape changing features of the link.

The protective cover can act on the link to increase or decrease themagnitude of the moments and forces applied to the bone fastener.

The protective cover can be movable or contains an adjustor that acts onthe link to increase or decrease the magnitude of the moments and forcesapplied to the bone fastener.

The protector cover can contain the adjustor. The adjustor can be ascrew.

In general, in another embodiment, the invention features an apparatusfor percutaneous bone fastening. The apparatus includes anextracorporeal link. The extracorporeal link includes a plurality oftransverse holes. The plurality of transverse holes (which holes can be,but are not limited to, slots or openings) are located about theextracorporeal link. Each transverse hole in the plurality of transverseholes is capable of allowing a bone fastener to pass through thetransverse hole in the plurality of transverse holes to secure to one ormore bone segments. The extracorporeal link is capable of beingconfigured in a first configuration. The extracorporeal link isconfigured in a second configuration. The apparatus further includes arestraining instrument. The extracorporeal link is operativelypositioned by the restraining instrument. The operative positioning ofthe instrument holds the extracorporeal link in the secondconfiguration. When released from the operative positioning of therestraining instrument, the extracorporeal link operatively moves towardthe first configuration to apply moments and forces to the bone fastenerby mis-aligning the traverse holes.

Implementations of the invention can include one or more of thefollowing features:

The movement toward the first configuration can be capable of applyingmoments and forces to the bone fastener.

The moments and forces capable of being applied to the bone fastener canbe operable to act through the skin to transport and compress the one ormore bone segments.

The restraining instrument can include a restrainer selected from agroup consisting but not limited to of pliers, power screws, slidingplatens, forceps, needle drivers, and pin tower tubes.

In general, in another embodiment, the invention features a method forusing an extracorporeal link for connecting percutaneous bone fasteners.The method includes selecting an element. The element includes aplurality of transverse holes. The plurality of transverse holes arelocated about the element. Each transverse hole in the plurality oftransverse holes is capable of allowing a bone fastener to pass throughthe transverse hole in the plurality of transverse holes to secure toone or more bone segments. The element is configured in a firstconfiguration. The method further includes restraining the element in asecond configuration. The element is restrained using external force.The method further includes positioning the element near, but notproximate to, one or more bone segments. The method further includespassing a plurality of bone fasteners through the plurality oftransverse holes. The method further includes releasing the element fromthe external force. Responsive to releasing the element from theexternal force, the element moves toward the first configuration. Themovement toward the first configuration applies moments and forces tothe plurality of bone fasteners by mis-aligning the link fastener holes.The moments and forces being applied to the plurality of bone fastenersact through the skin to transport and compress the one or more bonesegments.

Implementations of the invention can include one or more of thefollowing features:

The positioning of the element can adjust the moments and forces beingapplied to the plurality of bone fasteners.

The external force can be applied by a restraining instrument.

The restraining instrument can include a restrainer selected from agroup consisting of pliers, power screws, sliding platens, needledrivers, forceps and pin tower tubes.

In general, in another embodiment, the invention features a method formaking an extracorporeal link for connecting percutaneous bonefasteners. The method includes selecting a material. The materialincludes a memory-shape metal. The material is in a first configuration.The method further includes cooling the material. The material isoperable for being reconfigured to a second configuration. The materialis capable of remaining in the second configuration absent an externalforce. The material is capable of moving toward the first configurationat an elevated temperature. The method further includes, responsive tocooling the material, reconfiguring the material into the secondconfiguration. The method further includes responsive to reconfiguringthe material, restraining the material in a restraining instrument. Therestraining instrument restrains the material in the secondconfiguration at the elevated temperature. The method further includescontaining the extracorporeal link within a cover for protecting theextracorporeal link.

Implementations of the invention can include one or more of thefollowing features:

The material can be nitinol, plastic, spring steel, and strong andhighly elastic materials.

The material can be nitinol.

The cover can have a characteristic selected from the group consistingof being operable (a) to move to hide a bone fastener, (b) to releaseshape changing features of the extracorporeal link, (c) to holdantibiotic impregnated dressing, (d) to facilitate the release of thelink from the second configuration to the first configuration, and (e)combinations thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

Other advantages of the present invention will be apparent from thefollowing detailed description of the invention in conjunction withembodiments as illustrated in the accompanying drawings, in which:

FIG. 1A depicts a perspective view of a two pin link in the unstressedas manufactured first shape.

FIG. 1B depicts a perspective view of a two pin link in the retained andstressed second shape.

FIG. 2A depicts a perspective view of a three pin link in the unstressedas manufactured first shape.

FIG. 2B depicts a perspective view of a three pin link in the retainedand stressed second shape.

FIG. 3A depicts a perspective view of a four pin link in the unstressedas manufactured first shape.

FIG. 3B depicts a perspective view of a four pin link in the retainedand stressed second shape.

FIG. 4A depicts a side view of a two pin link with sliding covercontaining a link in the stressed second shape.

FIG. 4B depicts an orthogonal view of a two pin link with sliding covercontaining a link in the stressed second shape.

FIG. 4C depicts an orthogonal view of a two pin link with sliding coveropen and containing a link in the first shape.

LIST OF REFERENCE NUMERALS

-   1 Link member with two pins-   2 Link member with three pins-   3 Link member with four pins-   4 Link movable cover-   5 Link movable cover closed with link in a second shape-   6 Link movable cover open with link in a second shape and one side    of the cover outline but transparent.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a shape changing link that is usedexternal to the body to act on bone fasteners.

In particular, in certain embodiments, the shape changing link that isused external to the body to act on bone fasteners includes the linkthat can receive a plurality of bone fasteners as displayed in FIGS. 1A,1B, 2A, 2B, 3A, and 3B.

When fabricated, the link is formed in the first unstressed shape, asdisplayed in FIGS. 1A, 2A, and 3A (showing links members 1, 2, and 3,respectively). When instrument held, the link is in the stressedrecoverable second shape, as displayed in FIGS. 1B, 2B, and 3B. Whenheld wire, pin or other fasteners can be inserted through the holes,slots or openings in the link, through skin and into bone. When releasedfrom the instrument the link acts to recover its first unstressed shapethus acting to apply moments and forces on the k-wire or pin. The forcesand moments are created by the mis-alignment of holes or slots on thebottom and the top of the link and through bowing and shortening of thelink. The link acting on the k-wire or pin causes the tips of the bonefastener to move or if restrained by bone, forces to be applied to bone.

Height of the link above bone when the link is released from thestressed recoverable second shape toward the first unstressed shapeeffects the force or moments applied to the bone fastener. Since thefasteners can be inserted through holes in the link the height of thelink above bone is adjustable. As the height of height above bonedecreases, the magnitude of the moments applied to the fasteners, aproperty of the link, remains constant and bone fixation forcesincrease. Thus, by setting the height of the link above bone at apre-determined distance bone fixation forces can be controlled to apre-determined amounts for any given link. The magnitudes of momentsapplied to the bone fasteners can be set through the design of the link.

Generally, the fixation requirements are to stabilize and compresshealing bone. On occasion the clinical need is to distract the bones andthe link can be fabricated to either compress or distract. The link canhave a plurality of k-wires or pins and act on the pins in a pluralityof directions. The link can accept its pins or wires in a plurality ofshape changing holes to fixate a multitude of bones, bone fragments andbone anatomies.

The ability to program the link shape change to act on bone through theskin provides an endless number of link geometries acting on a pluralityof fasteners, wires and pins to program the bone movement or compressionto meet unique clinical needs. In certain embodiments, the pins, wiresand screws can be pulled together in a linear fashion, to a centrallocation or some other location driven by the link design and pinplacement strategy.

Due to the link being external to the body and not skin contacting thematerial for the link can be most any material that exhibits elasticbehavior. In some embodiments, the materials include, but are notlimited to, nitinol, titanium, stainless steel, polyethylene,polypropylene, polyester ether ketone, Teflon® and nylon. Thisconvenience allows a manufacturing cost reduction, a wide range ofelastic properties, designs and bone compressing options.

In clinical use, the link is held in a surgical instrument in a secondshape. This held shape is strained from its initial relaxed first shape,has the link pin holes aligned with one another and with the desiredbony location of the pin. The instrument held link can act as a guidefor the placement of the pins or wires. The surgeon will introduce eachpin or wire through the link, skin and into bone. X-ray visualizationenhances planning and placement of the link and its fixation pins orwires. Once all pins or wires are placed the surgeon releases therestraining instrument allowing the link to change shape, act on thepins or wires and compress the bony structures.

The instrument with link allows the surgeon to vary the distance of thelink above the skin and provides the surgeon the ability to adjust thebone fixation force by releasing the link at different locations on thepins. This change in the point of moment application of the link on thepin changes the force applied to bone. The shorter the distance betweenthe link and the bone the higher force imparted to the bone by themoment created by the link.

The pins, wires or other bone fastener, such as a screw can be used withthe link. If a screw the portion acted on by the link is unthreaded orthreaded. If unthreaded the link height can be adjusted in the samemanner as if a pin. If threaded the link may have threads and as thescrew is advanced bone is fixated and the link and screw are fastened toeach other in an adjustable manner.

The link at the point of penetration of a pin, wire or screw can becapped to cover the exposed end of the pin, wire or screw of have amovable cover that protects the fastener. This avoids any catching ofthe externalized fixation on things in the environment such as bandages,clothing, furniture etc.

When bone healing has occurred the link can be removed. To remove thelink the instrument is re-applied to the link and activated to returnthe link to its strained second shape. This re-aligns the pin holes withthe pins, removes any shortening or lengthening force and allows thelink to be slid off the pins or wires. Once the link is removed thewires or pins are removed by turning and pulling on the pins with adriver. Once the pins or wires are removed the small skin penetrationholes heal with only a bandage covering.

Due to the simple and minimally invasive nature of this inventionfailure to obtain the desired bone fusion result is not catastrophic forthe link and wire placement trauma is very low and its use does notpreclude a more invasive device and fixation techniques at a later date.

To provide for a number of link shapes, pin hole placements and pintypes the instrument that strains the link may by fabricated withmulti-link compatible designs or replaceable heads specific to each linkdesign. In this manner a single instrument that acts to strain the linkcan be used for many link designs.

The instrument must deform the link into its stressed second shape andretain it in this shape during use and if desired storage. It maycompress, stretch or align the pin holes of the link. The instrument'soperation can be based on mechanical designs including but not limitedto single or multiple action pliers, power screw driven compressingdevices (vice, clamp, pivoting levers for example), sliding or rotatingmechanism, forceps, needle drivers and other instruments that releasesthe link into the stressed second shape. See FIGS. 1B, 2B, and 3B.

The simple and disposable nature of the instruments, link, fasteners,pins and wires may allow the link system to be fully contained in asterile kit. This minimizes disease transmission, provides convenience,assures all components are available and speeds the operative procedure.The common availability of sterile k-wires and pins and the externalnature of the link and its instrument can allow this type of system tobe used with sterile pins and wires and a non-sterile link andinstrument.

The link can take many designs and a plurality of pins or wires.Accordingly, in certain embodiments, the link may have a plurality ofpin holes distributed on the link in a fashion so that their orientationincludes but is not limited to triangular, square, linear, or circular.

In some embodiments, the link can be designed to change shape in aplurality of directions so as to pull together, push apart, pull in asingle direction or a plurality of directions. In such an embodiment,this allows multiple pins in a single bone or in multiple bones to meetvariable clinical requirements for fixation. Thus, in some embodiments,the pin orientation relative to each other includes but is not limitedto parallel, divergent or convergent when being placed through the linkwhile it is being held in its stressed second shape.

A two pin link 1 is shown in FIGS. 1A and 1B. A three pin link 2 thatdeflects its pins and compression along a single axis is shown in FIGS.2A and 2B. A four pin link 3 that deflects its pins along a single axisis shown in FIGS. 3A and 3B changes shape in only one direction causingtwo sets of pins to come together. A link with multiple linearlyoriented bone fastener holes provide surgical flexibility in where toinsert the bone fixation pins. A link with transverse oriented pin holescan provide multi-axial rotational resistance to enhance fixation.

A link restraining, release and removal instrument is used to manipulatethe link. All designs restrain and release while others also allowengagement with a deployed link and its removal from the pins or wires.Levers rotating about a fulcrum not limited to pliers, needle drivers,and forceps can restrain, release and engage the link for removal.

Links made of superelastic nitinol limit the geometry of the links thatcan be cost effectively fabricated. Thin plates and tubing can be costeffectively fabricated with high superelastic behavior. Nitinol linkscan be held in a second stressed shape with an instrument.

Links of any design can be protected with a cover (such as the slidingcovers 4, 5, and 6 shown in FIGS. 4A, 4B, and 4C, respectively) thatprotects the end of the pins, link and that can be movable to releasethe link to its first shape allowing multiple direction of force andmoment application. This cover can be fabricated of materials notlimited to plastic, rubber, foam, or latex and fastened to or stretchedover the link and pins.

This cover can act on the link to adjust the moments and forces appliedto the bone fasteners. The cover can have features that push on the linkso as to deform it. This deformation may be caused by the cover geometryand movement or screws can thread through the cover to push on the linkto increase or decrease the moments of forces applied to the bonefasteners.

Although the extracorporeal bone compressing link of the presentinvention has been describe in connection with the shown embodiments, itis not intended to be limited to the specific forms set forth herein,but, on the contrary it is intended to cover such modifications,alternatives and equivalents as can reasonably be included within thescope and spirit of the invention as defined by the appended claims.

Additional variations of these embodiments will be obvious to those ofordinary skill in the art. Therefore, the spirit and scope of theappended claims should not be limited to the foregoing description. Onlythose claims specifically reciting “means for” or “step for” should beconstrued in the manner required under the sixth paragraph of 35 U.S.C.§ 112.

While embodiments of the invention have been shown and described,modifications thereof can be made by one skilled in the art withoutdeparting from the spirit and teachings of the invention. Theembodiments described and the examples provided herein are exemplaryonly, and are not intended to be limiting. Many variations andmodifications of the invention disclosed herein are possible and arewithin the scope of the invention. The scope of protection is notlimited by the description set out above, but is only limited by theclaims which follow, that scope including all equivalents of the subjectmatter of the claims.

Amounts and other numerical data may be presented herein in a rangeformat. It is to be understood that such range format is used merely forconvenience and brevity and should be interpreted flexibly to includenot only the numerical values explicitly recited as the limits of therange, but also to include all the individual numerical values orsub-ranges encompassed within that range as if each numerical value andsub-range is explicitly recited. For example, a numerical range ofapproximately 1 to approximately 4.5 should be interpreted to includenot only the explicitly recited limits of 1 to approximately 4.5, butalso to include individual numerals such as 2, 3, 4, and sub-ranges suchas 1 to 3, 2 to 4, etc. The same principle applies to ranges recitingonly one numerical value, such as “less than approximately 4.5,” whichshould be interpreted to include all of the above-recited values andranges. Further, such an interpretation should apply regardless of thebreadth of the range or the characteristic being described. The symbol“—” is the same as “approximately”.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood to one of ordinary skill inthe art to which the presently disclosed subject matter belongs.Although any methods, devices, and materials similar or equivalent tothose described herein can be used in the practice or testing of thepresently disclosed subject matter, representative methods, devices, andmaterials are now described.

Following long-standing patent law convention, the terms “a” and “an”mean “one or more” when used in this application, including the claims.

Unless otherwise indicated, all numbers expressing quantities ofingredients, reaction conditions, and so forth used in the specificationare to be understood as being modified in all instances by the term“about.” Accordingly, unless indicated to the contrary, the numericalparameters set forth in this specification are approximations that canvary depending upon the desired properties sought to be obtained by thepresently disclosed subject matter.

As used herein, the term “and/or” when used in the context of a listingof entities, refers to the entities being present singly or incombination. Thus, for example, the phrase “A, B, C, and/or D” includesA, B, C, and D individually, but also includes any and all combinationsand subcombinations of A, B, C, and D.

REFERENCES

-   U.S. Pat. No. 10,537,370, entitled “Bone Intramedullary Fixation    Scaffold,” issued Jan. 21, 2020 to William Casey Fox (“Fox '370    Patent”).-   U.S. Pat. No. 10,448,979, entitled “Shape Changing Bone Implants And    Method Of Use For Enhancing Healing,” issued Oct. 22, 2019 to    William Casey Fox (“Fox '979 Patent”).-   U.S. Pat. No. 10,123,831, entitled “Bone Compression Device And    Method,” issued Nov. 13, 2018 to Mathew P. Gephart.

What is claimed is:
 1. An extracorporeal link for connectingpercutaneous bone fasteners comprising an element wherein: (a) theelement comprises a plurality of transverse holes, wherein (i) theplurality of transverse holes are located about the element, and (ii)each transverse hole in the plurality of transverse holes is capable ofallowing a bone fastener to pass through the transverse hole in theplurality of transverse holes to secure to one or more bone segments;(b) the element is configured in a first configuration; (c) the elementis operable for being held under force in a second configuration; and(d) the element is operable to move toward the first configuration afterbeing released from the force, wherein (i) the movement toward the firstconfiguration is capable of applying moments and forces to the bonefastener by mis-aligning the link fastener holes, and (ii) the momentsand forces capable of being applied to the bone fastener are operable toact through the skin to transport and compress the one or more bonesegments.
 2. The extracorporeal link of claim 1, wherein theextracorporeal link is operatively positioned in a plurality of bonefragments.
 3. The extracorporeal link of claim 1, wherein the materialcomprises one or more cross-sectional geometries.
 4. The extracorporeallink of claim 1, wherein (a) each transverse hole in the plurality oftransverse holes is capable of guiding the bone fastener, and (b) thebone fastener is positioned through the extracorporeal link, skin, andthe bone.
 5. The extracorporeal link of claim 1, wherein the movementtoward the first configuration after being released from the forceoperatively positions the bone fastener to fixate, move or compress thebone at a desired direction.
 6. The extracorporeal link of claim 1,wherein the extracorporeal link is held by a restraining instrument in asterile kit.
 7. The extracorporeal link of claim 6, wherein therestraining instrument comprises a restrainer selected from a groupconsisting of pliers, power screws, sliding platens, forceps, needledrivers, and pin tower tubes.
 8. The extracorporeal link of claim 6,wherein the sterile kit comprises the extracorporeal link, therestraining instrument, a plurality of bone fasteners, and a pluralityof pin tower tubes.
 9. The extracorporeal link of claim 1, wherein theextracorporeal link is operatively connected to a protective cover. 10.The extracorporeal link of claim 9, wherein the protective covercomprises a material selected from a group consisting of plastic,rubber, latex, foam and combinations thereof.
 11. The extracorporeallink of claim 9, wherein the protective cover is movable and operates tocover cut bone fasteners or release other shape changing features of thelink.
 12. The extracorporeal link of claim 9, wherein the protectivecover can act on the link to increase or decrease the magnitude of themoments and forces applied to the bone fastener.
 13. The extracorporeallink of claim 12, wherein the protective cover is movable or contains anadjustor that acts on the link to increase or decrease the magnitude ofthe moments and forces applied to the bone fastener.
 14. Theextracorporeal link of claim 13, wherein the protector cover containsthe adjustor, and the adjustor is a screw.
 15. An apparatus forpercutaneous bone fastening comprising: (a) an extracorporeal link,wherein (i) the extracorporeal link comprises a plurality of transverseholes, (ii) the plurality of transverse holes are located about theextracorporeal link, (iii) each transverse hole in the plurality oftransverse holes is capable of allowing a bone fastener to pass throughthe transverse hole in the plurality of transverse holes to secure toone or more bone segments, (iv) the extracorporeal link is capable ofbeing configured in a first configuration, and (v) the extracorporeallink is configured in a second configuration; and (b) a restraininginstrument, wherein (i) the extracorporeal link is operativelypositioned by the restraining instrument, (ii) the operative positioningof the instrument holds the extracorporeal link in the secondconfiguration, and (iii) when released from the operative positioning ofthe restraining instrument, the extracorporeal link operably movestoward the first configuration to apply moments and forces to the bonefastener by mis-aligning the traverse holes.
 16. The apparatus of claim15, wherein the movement toward the first configuration is capable ofapplying moments and forces to the bone fastener.
 17. The apparatus ofclaim 16, wherein the moments and forces capable of being applied to thebone fastener are operable to act through the skin to transport andcompress the one or more bone segments.
 18. The apparatus of claim 15,wherein the restraining instrument comprises a restrainer selected froma group consisting of pliers, power screws, sliding platens, forceps,needle drivers, and pin tower tubes.
 19. A method for using anextracorporeal link for connecting percutaneous bone fasteners, themethod comprising: (a) selecting an element, wherein (i) the elementcomprises a plurality of transverse holes, (ii) the plurality oftransverse holes are located about the element, (iii) each transversehole in the plurality of transverse holes is capable of allowing a bonefastener to pass through the transverse hole in the plurality oftransverse holes to secure to one or more bone segments, and (iv) theelement is configured in a first configuration; (b) restraining theelement in a second configuration, wherein the element is restrainedusing external force; (c) positioning the element near, but notproximate to, one or more bone segments; (d) passing a plurality of bonefasteners through the plurality of transverse holes; and (e) releasingthe element from the external force, wherein (i) responsive to releasingthe element from the external force, the element moves toward the firstconfiguration, (ii) the movement toward the first configuration appliesmoments and forces to the plurality of bone fasteners by mis-aligningthe link fastener holes, and (iii) the moments and forces being appliedto the plurality of bone fasteners act through the skin to transport andcompress the one or more bone segments.
 20. The method of claim 19,wherein the positioning of the element adjusts the moments and forcesbeing applied to the plurality of bone fasteners.
 21. The method ofclaim 19, wherein the external force is applied by a restraininginstrument.
 22. The method of claim 19, wherein the restraininginstrument comprises a restrainer selected from a group consisting ofpliers, power screws, sliding platens, forceps and needle drivers andpin tower tubes.
 23. A method for making an extracorporeal link forconnecting percutaneous bone fasteners, the method comprising: (a)selecting a material, wherein (i) the material comprises a memory-shapemetal, and (ii) the material is in a first configuration; (b) coolingthe material, wherein (i) the material is operable for beingreconfigured to a second configuration, (ii) the material is capable ofremaining in the second configuration absent an external force, and(iii) the material is capable of moving toward the first configurationat an elevated temperature; (c) responsive to cooling the material,reconfiguring the material into the second configuration; (d) responsiveto reconfiguring the material, restraining the material in a restraininginstrument, wherein the restraining instrument restrains the material inthe second configuration at the elevated temperature; and (e) containingthe extracorporeal link within a cover for protecting the extracorporeallink.
 24. The method of claim 23, wherein the material is selected fromthe group consisting of nitinol. plastic, spring steel, and strong andhighly elastic materials.
 25. The method of claim 23, wherein thematerials is nitinol.
 26. The method of claim 23, wherein the covercomprises a characteristic selected from the group consisting of beingoperable (a) to move to hide a bone fastener, (b) to release shapechanging features of the extracorporeal link, (c) to hold antibioticimpregnated dressing, (d) to facilitate the release of the link from thesecond configuration to the first configuration, and (e) combinationsthereof.